FDA 510(k) Application Details - K223479

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K223479
Device Name	Subsystem, Water Purification
Applicant	B. Braun Medical Inc. 901 Marcon Blvd Allentown, PA 18109 US Other 510(k) Applications for this Company
Contact	Rushtin Chaklader Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	FIP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2022
Decision Date	08/16/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review